Clinical Trials Assistant in Witney

The Clinical Trial Assistant (CTA) provides essential administrative and operational support to ensure the effective conduct of commercial clinical research studies as part of Thames Valley Hampshire Primary Care Commercial Research Delivery Centre (TVH PC-CRDC).

Main duties of the job

• Working closely with trial staff and coordinators, investigators, and data management teams, the CTA assists with trial documentation, data entry, regulatory submissions, and sample or data logistics.
• This role is key to maintaining compliance with Good Clinical Practice (GCP), sponsor requirements, and organisational policies.
• This role will require some travel to GPs surgeries within the TVH PC-CRDC.

Job responsibilities

• Trial Administration – Provide administrative support for the set-up, conduct, and close-out of clinical trials. Archiving and secure disposal of documentation as instructed. Maintain study documentation, including Trial Master File (TMF) and Investigator Site File (ISF). Prepare and track essential documents such as delegation logs, ethics approvals, and training records. Assist in scheduling and organising trial-related meetings, site visits, and monitoring activities. Creation and monitoring of communications with participants including email and other messaging platforms e.g. Docmail, AccuRx. Monitoring and responding to enquiries arising from emails, telephone or other contacts in liaison with other members of the trials teams. Ensuring the working environment is kept tidy and accessible for research colleagues and practice users. Arranging, monitoring and organising team members to meet courier collections/deliveries bookings e.g. dispatch and receipt of samples and dry ice deliveries.
• Reception and Non-clinical Duties During Clinics Provide a friendly welcome to participants on arrival at clinic. Check documentation and non-clinical processes are completed as instructed. Maintain a tidy, organised clinic environment to ensure items are easily located and appropriately stored. Liaise with research clinicians to ensure the smooth running of the clinic.
• Data and Documentation Support data collection, data entry (electronic and paper based systems), and verification in accordance with study protocols. Filing and retrieval of documents within record storage systems. Use of photocopier to produce paper and scanned copies of documentation. Ensure accurate maintenance of participant screening and enrolment logs. Assist in the preparation and submission of regulatory and ethics documentation. Maintain version control of trial documents and ensure appropriate filing in accordance with SOPs.
• Sample and Logistics Management Support the coordination of biological sample collection, processing, and shipment (organise the schedules for collection, transport and receipt of samples). Track receipt and storage of trial materials, kits, and supplies. Monitor stock levels and ordering equipment and supplies as delegated. Participate in the ordering and receipt of transport medium e.g. dry ice and the recording and packing of samples for shipping off site. Maintain laboratory and other records to track samples and results. Following SOPs and Laboratory Manuals, record, process and store samples (e.g. nasal swabs, saliva and blood) to ensure adherence to trial requirements. Take action where samples are not received, processed, transported or reported as expected.
• Quality and Compliance Undertake required study specific training including relevant Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP). Ensure compliance with SOPs, GCP, GDPR, and local governance requirements. Participate in audits, monitoring visits, and inspections as required. Maintain confidentiality and data protection standards at all times.
• Communication and Support Liaise with investigators, clinical teams, and sponsors to provide timely trial updates. Contribute to meeting agendas, minutes, and progress reports. Attend meetings. Assist in training new research support staff or students as appropriate. Liaise with members of the wider trials team, participants, practice staff and other wider PC-CRDC colleagues and other stakeholders.

CONFIDENTIALITY The post holder may have access to confidential information relating to patients, their carers, practice staff and other healthcare workers. They may also have access to information relating to the PC-CRDC as a business organisation. All such information from any source is to be regarded as strictly confidential. Information relating to patients, carers, colleagues, other healthcare workers or the business of the PC-CRDC may only be divulged to authorised persons in accordance with the organisation policies and procedures relating to confidentiality and the protection of personal and sensitive data.

HEALTH & SAFETY The post holder will assist in promoting and maintaining their own and others health, safety and security as defined in the Health & Safety Policy.

EQUALITY AND DIVERSITY The post holder will support the equality, diversity and rights of patients, carers and colleagues to include: acting in a way that recognises the importance of peoples rights, interpreting them in a way that is consistent with the practice procedures and policies and current legislation. Respecting the privacy, dignity, needs and beliefs of patients, carers and colleagues.

Person Specification

• Knowledge and Skills Attention to detail including ability to follow instructions. Strong organisational and time management skills. Competent in Microsoft Office and database systems. Understanding of confidentiality and data protection. Knowledge of GCP and regulatory requirements. Familiarity with electronic data capture.
• Qualifications Educated to A-level or equivalent experience. Good standard of general education, particularly in English and numeracy. Degree or diploma in Life Sciences, Health, or related field. GCP certification.
• Personal Attributes Able to adapt to a changing working environment. Reliable, adaptable, and able to prioritise workload effectively. Commitment to maintaining quality and compliance. Enthusiastic and motivated to develop within clinical research.
• Experience Able to work on own initiative and as part of a team. Experience in administrative or research support role. Experience of working in a clinical trial environment. Experience of working with samples or other materials in laboratory or clinical setting. Understanding of clinical trial processes or research governance. Previous experience in a research, GP, NHS, or pharmaceutical environment. Experience maintaining study documentation (e.g., TMF).
• Mobility and Travel Requirements Able to travel to multiple GP locations across the Thames Valley and Hampshire PC-CRDC. Access to vehicle and full clean drivers licence.
• Communication and Teamwork Excellent written and verbal communication skills. Able to work collaboratively with multidisciplinary teams. Professional and proactive approach to problem-solving. Experience supporting multi-site or international trials.

Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.